Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT01405651
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2011-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603360', 'term': 'gemilukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations', 'timeFrame': 'At protocol-specified timepoints before and after study drug administration up to 21 days'}], 'secondaryOutcomes': [{'measure': 'Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests', 'timeFrame': 'At protocol-specified timepoints before and after study drug administration up to 21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ONO-6950', 'Healthy adult subjects'], 'conditions': ['Healthy Adult Subjects']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non-smoking male or female subjects (18-55 inclusive)\n* Body mass index (BMI)of 10-35 kg/m2 (inclusive)\n* For females; postmenopausal, non-lactating, and non-pregnant\n\nExclusion Criteria:\n\n* History or presence of clinical significant disease'}, 'identificationModule': {'nctId': 'NCT01405651', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'ONO-6950POU002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E', 'description': 'ONO-6950', 'interventionNames': ['Drug: ONO-6950']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'description': 'Placebo', 'interventionNames': ['Drug: ONO-6950']}], 'interventions': [{'name': 'ONO-6950', 'type': 'DRUG', 'description': '30 mg, 100 mg, 300 mg at multiple doses', 'armGroupLabels': ['E']}, {'name': 'ONO-6950', 'type': 'DRUG', 'description': 'Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950', 'armGroupLabels': ['P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Miramar Clinical Site', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}], 'overallOfficials': [{'name': 'Ono Pharma USA, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharma USA Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}